Telerehabilitation intervention after total knee arthroplasty in Iran: a feasibility and acceptability randomised controlled trial.

چکیده اصلی

OBJECTIVES: To assess the feasibility and acceptability of a culturally adapted telerehabilitation programme for Iranian patients following total knee arthroplasty (TKA) and to explore preliminary clinical outcomes to inform the design of a future definitive randomised controlled trial (RCT). DESIGN: Parallel-group, open-label, single-centre randomised controlled feasibility trial. SETTING: A private multi-specialty hospital in Tehran, Iran. PARTICIPANTS: Thirty adults aged 50-90 years undergoing primary TKA were randomised (1:1) using a block randomisation method to the intervention (n=15) or usual care (n=15); 27 participants completed the final assessment. Eligible participants were Persian-speaking adults with smartphone access. Patients with cognitive impairment, inflammatory or neurological disorders, sensory impairment, concurrent rehabilitation or postoperative complications precluding participation were excluded. INTERVENTIONS: Participants received either a 4-week culturally adapted telerehabilitation programme comprising 12 supervised virtual physiotherapy sessions delivered via a locally developed digital platform in addition to usual care or usual care alone. Participants were followed for 4 weeks, with the final assessment conducted at the end of the intervention period. OUTCOME MEASURES: Primary outcomes were feasibility (screening, recruitment and assessment completion rates) and acceptability (participant satisfaction, adherence, attendance, attrition and willingness to recommend the programme). Secondary exploratory outcomes included the Knee Injury and Osteoarthritis Outcome Score subscales, patient global assessment, walking aid use, exercise adherence, adverse events and receipt of outpatient physiotherapy. RESULTS: Fifty-nine patients were approached, and 30 were randomised (mean age 67.3 years; 76.7% women), with 27 completing the study. Prespecified feasibility targets were achieved, with screening, recruitment and retention rates of 86.4% (95% CI 75.0% to 94.0%), 69.8% (95% CI 53.9% to 82.8%) and 90.0% (95% CI 73.5% to 97.9%), respectively. The attrition rate was 10.0% (95% CI 2.1% to 26.5%). In the intervention group, acceptability was favourable, with mean satisfaction and adherence scores of 76.3 (SD 17.3) and 82.7 (SD 15.1), respectively; 83.3% of scheduled sessions were attended, and 84.6% of participants indicated that they would recommend the programme. Exploratory clinical outcomes were summarised descriptively to provide preliminary estimates for planning a future definitive trial. No intervention-related adverse events were reported. CONCLUSIONS: This pilot RCT demonstrated that a culturally adapted telerehabilitation programme following TKA was feasible, acceptable and safe in the Iranian setting. The exploratory clinical findings provide preliminary data to inform the design of a fully powered multicentre RCT to evaluate the clinical effectiveness, cost-effectiveness and long-term outcomes of this intervention. TRIAL REGISTRATION NUMBER: Thai Clinical Trials Registry, TCTR20231020004, registered on 8 October 2023.

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